UMIN-CTR Clinical Trial

Basic information
Public title	Multi-omics cohort analysis and biobank construction in Japanese patients with inflammatory bowel disease
Acronym	IBD-MOCHA
Scientific Title	Multi-omics cohort analysis and biobank construction in Japanese patients with inflammatory bowel disease
Scientific Title:Acronym	IBD-MOCHA
Region	Japan

Condition
Condition	Inflammatory bowel disease Crohn's disease Ulcerative Colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Factors involved in the development and prognosis of inflammatory bowel disease
Basic objectives2	Others
Basic objectives -Others	Omics analysis to search for factors involved in the above and construction of a biobank of specimens for this purpose.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Genetic factors involved in pathogenesis
Key secondary outcomes	Serum proteins, gut microbiota, and genetic background related to prognosis and pathology

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Inflammatory bowel disease (Crohn's disease, ulcerative colitis, unclassifiable enteritis) or suspected cases
Key exclusion criteria	Cases in which the cause of enteritis symptoms is obvious (infectious enteritis, ischemic enteritis, diverticulitis, etc.) Other cases that the attending physician considers inappropriate
Target sample size	5500

Research contact person
Name of lead principal investigator	1st name Yoichi Middle name Last name Kakuta
Organization	Tohoku University Hospital
Division name	Division of Gastroenterology
Zip code	980-8574
Address	1-1 Seiryo Aoba, Sendai
TEL	0227177171
Email	ykakuta@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Yoichi Middle name Last name Kakuta
Organization	Tohoku University Hospital
Division name	Division of Gastroenterology
Zip code	980-8574
Address	1-1 Seiryo Aoba, Sendai
TEL	0227177171
Homepage URL
Email	ykakuta@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tohoku University Graduate School of Medicine Ethics Committee
Address	1-1 Seiryo Aoba, Sendai
Tel	022-728-4105
Email	med-kenkyo@grp.tohoku.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2022 Year 03 Month 28 Day
Date of IRB	2022 Year 03 Month 30 Day
Anticipated trial start date	2022 Year 03 Month 31 Day
Last follow-up date	2027 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Course of treatment, medical history, etc.

Management information
Registered date	2022 Year 02 Month 06 Day
Last modified on	2022 Year 04 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053441